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Drugs Approved Under Deadline More Likely to Run Into Trouble Later
Date:3/26/2008

but to do so in a way that doesn't put the FDA in the bind of making decisions too quickly and without adequate consideration of the implications."

Carpenter and his colleagues used a mathematical model to look at the association between PDUFA deadlines, the timing of FDA drug approval and the likelihood of post-marketing safety problems in drugs approved since 1950. The study is published in the March 27 issue of the New England Journal of Medicine.

After PDUFA was initiated, approval decisions tended to be concentrated in the two months preceding the deadlines.

Drugs approved before the looming deadline were more than five times more likely to be withdrawn from the market for safety reasons; more than four times more likely to have to add a black-box warning; and more than three times more likely to have one or more dosage forms voluntarily discontinued by the manufacturer.

Some examples provided by Carpenter:

  • Baycol, a statin approved exactly one day to the year after the application was submitted, and withdrawn four years later due to reports of death from rhabdomyolysis, a breakdown of muscle fibers.
  • The diabetic drug Rezulin was given priority status, approved before the six-month deadline, then given a black-box warning, withdrawn from the market, and eventually reintroduced.
  • The infamous arthritis drug Vioxx was also a priority drug, approved within six months and later withdrawn because of cardiac side effects, to much hoopla.

"In doing a lot of interviews at the FDA, they'll tell you that the culture of CDER [Center for Drug Evaluation and Review] is fairly dominated by these review deadlines," said Carpenter, who is writing a book on the FDA.

But this doesn't necessarily mean the FDA should do away with deadlines altogether, Carpenter said.

"It strikes me we should think about deadlines less and on resources more for accelerating
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